Abbott Receives CE Mark for Smaller-Size XIENCE™ V Drug Eluting Stent
New 2.25 mm Diameter Stent Now Available in Europe, Asia and Latin America
Abbott Park, Illinois (NYSE: ABT) — Abbott announced today that it has received CE Mark (Conformité Européene) approval for a 2.25 mm version of its XIENCE™ V Everolimus Eluting Coronary Stent System, offering physicians a smaller stent based upon the proven efficacy, positive safety results and excellent deliverability of XIENCE V. The addition of the 2.25 mm stent to the XIENCE V portfolio gives physicians access to a wider range of stent sizes for treating a variety of patient types.
“Lesions in small vessels tend to be more complex and challenging to treat, so it’s important to have a drug eluting stent with proven clinical benefits that can be easily delivered to the diseased area of the vessel,” said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. “With XIENCE V 2.25 mm, physicians now have access to a smaller stent that combines these critical attributes with the positive safety outcomes we have seen with XIENCE V. These outcomes include low rates of reintervention in the diseased vessel, low rates of heart attack and death, and low rates of vessel renarrowing following treatment.”
The 2.25 mm version of the XIENCE V stent will be launched immediately in the majority of European markets and select countries in Asia and Latin America. In addition to the 2.25 mm stent, XIENCE V is available in stent diameters of 2.5 mm, 2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm for lesions 28 mm or shorter.
Coronary artery disease (CAD) occurs when arteries become narrow due to plaque buildup, restricting blood flow to the heart. Approximately 30 to 40 percent of CAD lesions occur in vessels equal to or less than 2.5 mm in diameter.
XIENCE V is the only drug eluting stent to demonstrate superiority over another drug eluting stent in a randomized clinical trial. In the SPIRIT family of trials, XIENCE V demonstrated:
* Superiority for XIENCE V compared to TAXUS® paclitaxel eluting coronary stent system in the primary endpoint of angiographic In-Stent Late Loss in the SPIRIT II clinical trial at six months, with a statistically significant 69 percent reduction for XIENCE V. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.
* Superiority for XIENCE V compared to the TAXUS in the primary endpoint of angiographic In-Segment Late Loss at eight months in the SPIRIT III clinical trial, with a statistically significant 50 percent reduction for XIENCE V. In-segment late loss is a measure of vessel renarrowing.
* An observed 43 percent reduction in major adverse cardiac events (MACE) compared to TAXUS at one year in SPIRIT III. MACE is an important clinical measure of safety and efficacy outcomes for patients, and is defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR associated with symptoms or documented lack of blood supply).
* Non-inferiority to TAXUS with an observed 23 percent reduction in Target Vessel Failure (TVF) for XIENCE V compared to TAXUS in the SPIRIT III clinical trial at one year. Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack.
Additionally, data from an independent pooled subset analysis of SPIRIT II and SPIRIT III at one year showed:
* A statistically significant 59 percent reduction in angiographic In-Stent Late Loss for XIENCE V compared to TAXUS for lesions in a reference vessel diameter less than 2.5 mm.
* An observed 61 percent reduction in angiographic In-Segment Late Loss for XIENCE V compared to TAXUS for lesions in a reference vessel diameter less than 2.5 mm.
XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
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